Product Quality Engineer

ABOUT ORGANOX:

OrganOx is a commercial stage organ technology company dedicated to developing technologies to improve outcomes for patients with acute or chronic organ failure. The company was established as a spin out of the University of Oxford in 2008 and is now part of the Terumo Group. OrganOx is a pioneer in normothermic machine perfusion (NMP). It's flagship platform, the metra®, is available for use in the U.S., Europe, Canada, and Australia. It has been utilized in over 7,000 liver transplants to date to keep donor livers in a metabolically active state outside the body enabling longer preservation times and functional assessment of the organ prior to transplant, leading to an increased number of organs available for transplant. Founded in 1921, Terumo Corporation (TSE:4543) strives to fulfil its mission of “Contributing to Society through Healthcare” by providing a comprehensive range of solutions in the fields of therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions.

Position Summary

The Product Quality Engineering team at OrganOx is a technical quality engineering team responsible for monitoring, understanding, and improving product performance of the OrganOx Metra, a Class III medical device. The Product Quality Engineering team works closely with Product Sustaining Engineering and Contracted Suppliers to set in place quality control and management processes for externally built products and componentry, including sterilization and microbiology, supplier management, and contract manufacturing processes.

The Product Quality Engineer will have strong technical skills with an ability to analyze product quality issues and work cross-functionally to solve problems related to product quality.

The successful candidate is collaborative, has excellent communication and problem-solving skills, and is passionate about delivering world-class products that make healthcare more accessible, simpler, and safer.

This is a flexible, on-site role in Oxford, UK.

Listed below are the major responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally exhaustive.

Major Responsibilities

Under direction from the Senior Product Quality Engineer and Senior Manager, Product Quality Engineering, the Product Quality Engineer may be responsible for the following:

Analyze and trend on product performance data to provide recommendations for product improvements

Investigation and disposition of nonconforming material through Non-Conforming Material (NCMR) and Supplier Corrective Action Reports (SCARs) processes in response to product performance trends.

Support root cause investigation and timely closure of SCARs

Work cross-functionally with other engineering teams and contracted suppliers to implement changes in manufacturing and inspection procedures to mitigate field failures.

Maintain good working relationships with suppliers to support root cause investigation and failure mitigation efforts

Supports updates to supplier quality agreements

Support hands-on analyses of returned products to identify root causes of failures

Support development of investigation criteria and test methods to properly diagnose and root cause field failures

Provide technical insight to sterilization and microbiological processes

Support CAPAs, Escalations, and engineering investigations in response to field quality issues.

Participate in the development and review of engineering change orders that impact product quality activities

Perform DHR, Service History record, and PFMEA reviews in support of complaint investigations

Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies.

Requirements

Skills & Experience

Demonstrable related hands on engineering experience in the medical device industry, or equivalent.

Knowledge of electro-mechanical troubleshooting techniques

Familiarity with ISO14971 and associated Risk Management Processes is a plus

Knowledge of medical device sterilization and microbiology preferred

Excellent technical report writing skills

Strong Root Cause Analysis, Design Of Experiments, and test method development experience as related to complaint investigations

Experience investigating and resolving SCARS and CAPAs

A solid understanding of the FDA QSR Quality System Requirements, and the ability to apply the knowledge to comply with goals and objectives.

Strong experience with MS Office Products (Word, Excel, Visio, Project, PowerPoint, Outlook, etc.)

Strong experience with statistical analysis of data. Experience with Minitab preferred.

Experience with Six Sigma principles preferred.

Excellent oral and written communication skills with the ability to communicate with audiences of varying technical skills

A strong ability to prepare written technical plans and reports in support of engineering changes, product or process validations, and failure investigations.

Strong focus on meeting customer needs.

Proven ability to work cross functional and within global teams, fostering a culture of high collaboration.

Ability to be self-driven and solve complex problems independently. Committed to upholding OrganOx values in daily work and decision-making.

Experience in driving a global quality mindset across teams and geographies.

Demonstrated strong attention to detail and “do it right the first time” attitude

Qualifications

Bachelor’s degree in an Engineering discipline (Electrical, Mechanical, Bio-Medical, etc.) or the equivalent work experience

Ability to travel 10-20%

Six Sigma Green Belt or Black Belt Certification preferred

Benefits

At OrganOx, we value innovation, evidence, integrity, teamwork, respect, and passion. We offer competitive compensation and comprehensive benefits, including healthcare and retirement plans. We support work-life balance and provide opportunities for ongoing professional development.